Antistatic valve holding chamber

An Important Advancement in
Valved Holding Chamber Technology

Excellence by Design
 Why use AeroChamber Plus* VHC with
Flow-Vu* Inspiratory Flow Indicator (IFI)?
The pressurized Metered Dose
Inhaler (pMDI) is the most
commonly prescribed aerosol
medication system and is predicted
to continue to play a strong role in
treatment over the next 10-15
years†.
 Effective pMDI therapy is
based on proper technique
 Many patients (especially
children) have poor pMDI
technique
 Medication deposited in the
mouth and throat is
swallowed and could have
systemic effects

P. Barnes, J.C. Virchow, J. Sanchis, T. Welte and S.

†

Pedersen. Asthma management: important issues. European Excellence by Design

Respiratory Review, Volume 14, Number 97: 147-151.
 Particle Deposition – Size Distribution
 Typical pMDIs deliver a dose at over†
60 miles per hour (100 km per hour)
 Without a VHC, 60 – 80% of the
released dose deposits in the upper
airway (increasing potential for
systemic absorption) and ~20%
passes into lower pulmonary tract
 VHCs minimize oropharyngeal (mouth
& throat) deposition by reducing the
speed at which the aerosol is
delivered and by
removing larger (>4.8 µm)
non-respirable particles.

†
Newman S. “Deposition and Effects of Inhalation Aerosols”. Excellence by Design
Lund, Sweden; AB Draco; 1983, 13-22
Particle Deposition – Size Distribution
AeroChamber Plus* VHC with Flow-Vu* IFI used with a
metered dose inhaler helps optimize delivered particle size:

 Nose: particles >10 µm

removed
 Mouth: particles >15 µm
removed
 Tracheo-bronchial:
particles 5-10 µm
 Pulmonary deposition:
Particles 1-5 µm

Excellence by Design
Particle Deposition – Size Distribution
← Tracheo-bronchial
~5 µm

← Bronchio-alveolar
<3 µm

Excellence by Design
The rejuvenated pressurized metered dose inhaler
Expert Opin. Drug Deliv.(2007) 4(3):215-234

1. Propellants - - CFC or HFA

CFC-12(11,114)
HFA-134a,HFA-227
2. Surfactants - - oleic acid
for suspensions drug
3. Ethanol - - for solution drug
4. Actuators - - diameter
(0.6 mm,0.12-0.3mm)

Excellence by Design
The rejuvenated pressurized metered dose inhaler
Expert Opin. Drug Deliv.(2007) 4(3):215-234

5. Speed - - CFC or HFA

CFC -- over30m/s
HFA -- 2.0-2.7m/s
6. Duration - -
CFC 0.1 – 0.2 s
HFA 0.21 – 0.36 s
7. Impact force - -
CFC 75-125mN
HFA 25mN
8. Temperature - -
CFC -20 – -30°C
HFA > 0°C
Excellence by Design
The rejuvenated pressurized metered dose inhaler
Expert Opin. Drug Deliv.(2007) 4(3):215-234

9. Reprimed - - CFC or HFA

CFC – 24 to 48 h
HFA – 4 to 7days

Excellence by Design
 History
Developed from work
The pressurized
metered dose by Newhouse,
inhaler (pMDI) was Dolovich & colleagues
25 Years of
developed at Firestone Institute of
Continuous
Respiratory Health,
Improvement
Hamilton, Ontario

1950s 1980s 2000 Present

For the first 25 years, patients

actuated the pMDI directly into the Patient Need: Make it easier to use the
mouth: pMDI
- Unwanted oropharyngeal deposition
(side-effects with corticosteroids) Clinician Need: Increase the consistency of
- Required excellent coordination to
aerosol medication delivery
optimize aerosol delivery

Excellence by Design
 Compact Size for Portability

100 120
< 2.8μm
AEROSOL DELIVERED AS % OF

AEROSOL DELIVERED AS % OF
100 < 2.8μm
80
ORIGINAL MDI DOSE

ORIGINAL MDI DOSE

80
60

60

40
40
> 2.8μm
20
20

> 2.8μm
0 0
0 2 4 6 8 10 12 14 0 1 2 3 4 5 6 7

LENGTH OF CHAMBER (CM) DIAMETER OF CHAMBER (CM)

• Chamber volume of AeroChamber Plus* VHCs is 149-ml

• Compact in comparison to other VHCs
– Optimal performance-size characteristics

Corr, D., Dolovich, M., McCormack, D., Ruffin, R., Obminski, G and
Newhouse M. 1982. Design and characteristics of a portable breath
actuated, particle size selective medical aerosol inhaler. J. Aerosol Sci.,
13(1):1-7 Excellence by Design
 Factors that may result in in consistent
medication delivery from VHCs

Device related:
• Electrostatic charge
• Incorrect operation of inhalation and
exhalation valves
• Facemask
• Size(volume) of VHC--- infants and small
children

Primary care respiratory journal 2007;16(4):207-214

Excellence by Design
 Factors that may result in in consistent
medication delivery from VHCs
Patient related:
• Choice of appropriate VHC and patient
interface(mouthpiece or facemask) –
infant, child, adult
• Patient inhalation modality
• Disease modality and severity – may
affect ability to use a particular patient
interface
Primary care respiratory journal 2007;16(4):207-214 Excellence by Design
 Device –related factors
Electrostatic charge
Electrostatic charges arise as the result of
friction generated by the Contact and separation of dissimilar
materials
•Antistatic materials VHCs that can increased more
than two- fold in the lower respiratory tract
-- by 1.Drug Delivery Technol 2004;4:1-5
2.Encyclopedia of pharmaceutical Technology 2nd Edition. NewYork;
Taylor &Francis,2005.p.1-14
3.Respiratory Drug Delivery-VI. Buffalo Graove, IL. USA: Interpharm
Press, 1998. p.227-33

Excellence by Design
 如何減少靜電的產生
• Pre-washing with ionic detergent
• VHCs manufatured from good electrical-
conducting materials(such as steel or aluminum)
Fine particle mass with 2s delay (μg)
VHC( Valved holding
Type No pre-tretment Pre-washed and
chamber) (out of package) rinesed

AeroChamber Max® Charge dissipative polymer 23.8 ± 4.8 21.5 ± 3.2

Vortex® Conducting metal( aluminum ) 16.2 ± 1.7 15.5 ± 2.0

OptiChamber® Non-conducting polymer 2.6 ± 1.2 6.7 ± 2.3

Advantage
ProChamber™ Non-conducting polymer 1.6 ± 0.4 5.1 ± 2.5

Breathrite™ Non-conducting polymer 2.0 ± 0.9 3.2 ± 1.8

PocketChamber® Non-conducting polymer 3.4 ± 1.6 1.7 ± 1.6

ACE® Non-conducting polymer 4.5 ± 0.9 5.4 ± 2.9

Excellence by Design
 Device – related factors
VHC valve function:
 It is very important issue for neonates or infants if
the valves are stuck closed.
 The ability to observe valve movement in
response to patient breathing is a significant
benefit .
1. Respir care 2000;45(6):623-35.
2. J Asthma 1997;34(6):443-67.
3. Pediatr Asthma Allergy Immunol 2004;17(4):292-300.
Valve 4. Raspir Med 2006;100:1479-94.

Excellence by Design
 Device – related factors
VHC size(volume):
 Chamber volume can also affect medication
delivery , but VHCs between 150 to 250 ml capacity
are for the most part as effective as 750 ml devices.

1. J Aerosol Sci 1982;13(1):1-7.

2. Respir care 1999;44(1):38-44.
3. Aerosol Sci Technol 1993;18(3):230-40.
4. Br J Clin Pharmacol 1999;47:333-6.
5. Adv Drug Daliv Rev 2003;55:869-78.
6. J Aerosol Med 2007;20(suppl.1):S29-S45

Excellence by Design
 Device – related factors
Facemask-to-face seal integrity:
 Flexible facemask - comfortable and reduced
dead volume
 VHCs in which the movement of both inhalation
and exhalation valves in response to the breathing
cycle of the patient is visible.

1. Eur Respir J 2000;16:850-6.

2. J Aerosol Med 2004;17:1-6
3. Pediatr Allergy Immunol 2005;16:348-53
4. Pediatrics 2001;108:389-94
5. Pediatr Asthma Allergy Immunol
2004;17(4):292-300

Excellence by Design
 AeroChamber Plus* VHC with
Flow-Vu* IFI
AeroChamber Plus* VHC with Flow-Vu* IFI with Child or Infant mask
enables paediatric patients, who cannot properly actuate a pMDI, to
use aerosol medications effectively.        

“Delivery of aerosols to children

with pMDI and Valved Holding
Chambers is critically dependent
on the Facemask Seal.” †

† Amirav et al, Study Presented at ALA/ATS Congress, 1999 Excellence by Design

 Facemask with Minimal Dead Volume
and Comfortable Fit
120
ComfortSeal*
100 facemask with curved
AeroChamber Plus*
lip, manufactured
80 Optichamber
from soft silicone
elastomer conforms
Dead Space %

Easivent
60 Ace
to facial contours
BreatheRite
40 Vortex • Ensures a reliable seal
Pocket Chamber
with as little as 0.7 kg
applied force (gentle)
20
• Minimizes dead volume
0
1.5 3.5 7
Pressure lbs

Shah, S.A., Berlinski, A. and Rubin, B.K. 2006. Force-dependent static dead
space of face masks used with holding chambers. Respir Care. 51(2):140-144.
Everard, M.L. 1995. Trying to deliver aerosols to upset children is a thankless
task. Arch. Dis. Child. 82:428. Excellence by Design
 AeroChamber Plus* VHC with
Flow-Vu* IFI – ComfortSeal* Mask
 The EZ Flow exhalation EZ Flow
valve is built into the mask to Exhalation Valve
minimize deadspace and
reduce resistance when the
patient exhales
 Patients can exhale with the
mask in place, maintaining an
effective facemask seal
necessary for efficient
aerosol delivery
 A protective dome ensures
the exhalation valve is
virtually tamper-proof

Excellence by Design
AeroChamber Plus* VHC with
Flow-Vu* Inspiratory Flow Indicator
Provides assurance to patients, caregivers and healthcare professionals that
inhalation is performed correctly.
Three Flow-Vu* IFI Benefits
1. Allows caregivers to count
patient breaths
2. Ensures a satisfactory
facemask seal
3. Allows actuation in
unison with
inspiratory flow

Excellence by Design
AeroChamber Plus* VHC with
Flow-Vu* IFI – Features and Benefits

Flow Dynamic
Design increases
suspension time
for aerosol
medications FLOWSIGnal* Whistle (on Mouthpiece
and Large Mask Products) provides
feedback when the patient is
inhaling too rapidly

Excellence by Design
AeroChamber Plus* VHC with
Flow-Vu* IFI – ComfortSeal* Mask
The ComfortSeal* mask sets us apart from any
other Chamber on the Market.

Infant Mask
0-18 months

Child Mask
12 months – 5 years

Large Mask
5 years +

Excellence by Design
 Visibility of Aerosol Formation

• An important part of providing

patient/health caregiver
feedback

• AeroChamber Plus* VHCs

and AeroChamber Plus*
VHCs with Flow-Vu* IFI retain
transparency in body so that
aerosol plume can be seen
when inhaler is actuated

Dolovich M.B. 2004. In my opinion: Interview with the

expert. Pediatr. Asthma Allergy Immunol. 17(4):292-300. Excellence by Design
 Flow-Vu* Inspiratory Flow Indicator (IFI)

Three Flow-Vu* IFI Benefits

1. Allows caregivers to count
patient breaths
2. Ensures a satisfactory
facemask seal
3. Allows actuation in unison with
inspiratory flow

“Devices should be easy

to use and incorporate
multiple feedback
mechanisms which
reassure the patient that
medication has been
delivered.”

P. Barnes, J.C. Virchow, J. Sanchis, T. Welte and S. Pedersen.

Asthma management: important issues. European Respiratory Excellence by Design
Review, Volume 14, Number 97: 147-151. )
 Coaching Aid to Encourage
Slow, Deep Inhalation

FlowSignal* Whistle
provides an audible
warning if inhalation
flow rate is much in
excess of 40 L/min

Dolovich M.B. 2004. In my opinion: Interview with the

expert. Pediatr. Asthma Allergy Immunol. 17(4):292-300.
Demirkan K, Tolley E, Mastin T, Soberman J, Burbeck J
and Self T. 2000. Salmeterol administration by metered-
dose inhaler alone vs. metered-dose inhaler plus valved Excellence by Design
holding chamber. Chest. 117:1314-1318.
AeroChamber Plus* VHC with
Flow-Vu* IFI – Product Range
Recommended for:
 any child under the age of 6
 individuals who would like more control of their inhalation technique
 anyone who experiences difficulty taking long, deep breaths or
holding their breath for the required 10 seconds
 those who would like to lessen the unpleasant
taste of some drugs
 use with either CFC or HFA pMDI formulations
 patients who need accurate and consistent
dose delivery

Excellence by Design
 Free from BPA, Phthalates, Latex, Lead and PVC

• The decision to offer a BPA Free product line is in

response to general consumer demand for products that
do not include Bisphenol A

• We have chosen to offer BPA free technology in advance

of any regulatory requirements imposed by government

Excellence by Design
Can be used with all commonly prescribed
metered dose inhalers

Excellence by Design
Clinical Guidelines – Recommending Use
National Institute for Clinical Excellence, UK (NICE)
 Spacer/Holding Chamber recommended with a facemask where
necessary for both corticosteroids and bronchodilators (Children
under 5)
 A press-and breathe pMDI used with an appropriate Spacer/Holding
Chamber is first choice for corticosteroids (Children 5 – 15 years)
 COPD Guideline – pMDI alone is rarely suitable for
use with the elderly

Excellence by Design
Clinical Guidelines – Recommending Use
British Thoracic Society / Scottish Intercollegiate
Guidelines Network, UK (BTS / SIGN)
 Children and adults with mild and moderate exacerbations of
asthma should be treated by bronchodilators given from a pMDI +
Spacer or Holding Chamber with doses titrated according to
clinical response
 Use Spacer/Holding Chamber with facemask for children
aged 0 to 5 years
 Use pMDI + Spacer/Holding Chamber in children
5-12 years of age receiving corticosteroids

Excellence by Design
Clinical Guidelines – Recommending Use
Global Initiative on Asthma (GINA)
 pMDI + dedicated Spacer/Holding Chamber with facemask
is the recommended inhaler choice for children 4 years of
age and younger
 pMDI + dedicated Spacer/Holding Chamber with
mouthpiece is the recommended inhaler choice for children
between 4 and 6 years of age

Excellence by Design
Clinical Guidelines – Recommending Use
National Heart, Lung, and Blood Institute (NHLBI)
 All patients taking inhaled steroids should use a
Spacer/Holding Chamber
 Patients under 5 years should use a Spacer/Holding
Chamber with Facemask for inhaled steroids

Excellence by Design
Clinical Guidelines – Recommending Use
Global Asthma Physician and Patient Study (GAPP)
 Asthma medication compliance is low; patients with poor
compliance experience more symptoms; and side effects lead
patients to switch or drop medications
 69% of the time, physicians do not discuss correct inhaler
technique with their patients
 31% of patients skip medication doses as a result of
side effects from their asthma medication

Excellence by Design
 History of the AeroChamber* Brand
of Valved Holding Chamber
AeroChamber* AeroChamber Plus* VHC
with Flow-Vu* Inspiratory
VHC with Mask and
AeroChamber* VHC AeroChamber Plus* Flow Indicator provides
addition of
Mask with Exhalation VHC with more assurance that inhalation is
FlowSignal* Whistle
Valve responsive valves performed correctly
to MP and Large
Mask

1983 1987 199 1994 1996 1999 2004 2006

3

AeroChamber MAX* VHC with

AeroChamber* AeroChamber* AeroChamber*VHC Anti-Static barrel introduced in N.
VHC VHC Clear Body with Round Mask America. Maximizes aerosol
suspension
time & drug availability

Excellence by Design
 Chambers Designed for Specialized Populations

AeroTrach Plus* AeroKat* Feline

VHC Aerosol Chamber
• Patients with • Domestic cats with
tracheostomy Asthma

AeroChamber MV* AeroDawg* Canine

HC Aerosol Chamber
• Patients on • Dogs with chronic
mechanical ventilation bronchitis

AeroVent* CHC AeroHippus* Equine

(collapsible) Aerosol Chamber
• Patients on • Horses with
mechanical ventilation Respiratory Disease

Excellence by Design